System and method for pelvic floor repair

ABSTRACT

A method of repairing a pelvic floor disorder and a system for carrying out the method are provided. The method is effected by positioning an imaging device in an abdominal, rectal, perianal or vaginal cavity, advancing a surgical instrument through a vaginal wall under guidance of the imaging device to thereby reach a target tissue and using the surgical instrument to attach the tissue repair device to the target tissue.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/366,002 filed on Jun. 17, 2014, which is a National Phase of PCTPatent Application No. PCT/IL2012/050548 having International FilingDate of Dec. 20, 2012, which claims the benefit of priority under 35 USC§119(e) of U.S. Provisional Patent Application No. 61/578,261 filed onDec. 21, 2011. The contents of the above applications are allincorporated by reference as if fully set forth herein in theirentirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to a system and method for rapid, safe andaccurate access to pelvic floor tissues with minimal tissue trauma.Embodiments of the present invention relate to a system capable ofguiding the positioning of a tissue repair device and/or implant intreatment of pelvic organ prolapse and pelvic floor herniation and/orrelaxation.

Trans-vaginal pelvic floor repair is a surgical procedure which utilizesblunt tissue dissection to provide access to the sacrospinous ligamentfrom the posterior vaginal wall. A sling or mesh is then anchored to thesacrospinous ligament and the vaginal apex or the uterine isthmicalfibrotic ring, cervix or body, to thereby support prolapsing tissuesand/or organs.

Although pelvic floor repair is a common procedure, access to thesacrospinous ligament is typically effected by improvised manual bluntdissection techniques and/or use of off the shelf instruments.

Centro-apical reconstruction is key for proper pelvic organ prolapse(POP) repair. The premium supportive pelvic structure is thesacro-spinous ligament (SSL) which is positioned at the posterior aspectof the pelvis. The SSL is a robust ligament and thus provides a longlasting solution. Since it is positioned high in the pelvis and mediallythe SSL provides a level 1 support (DeLancey) and reduces the likelihoodof dyspareunia when utilized for prolapse repair.

Vaginal wall access to the SSL can be difficult and hazardous sinceorgans and tissues surrounding the access path can easily be injuredduring dissection. Present day approach for accessing the SSL startswith an incision at the mid-line of the posterior or anterior vaginalwall followed by lateral dissection under the sub-mucosal fascia to thepelvic side wall and dissection towards the ischial spine to the mid SSL(MSSL).

This approach decreases risk of tissue injury by bypassing thebladder/rectum while maintaining accurate navigation along the abovementioned landmarks. Such an approach requires a high degree of skilland as such can lead to a high rate of complications; this prompted theFDA to issue a significant risk warning associated with POPreconstruction.

While reducing the present invention to practice, the present inventorshave devised a system and method which can be used to directly accessanatomical landmarks and structures such as the ischial spine and thesacro-spinous ligament from the vaginal cavity as well as guide a tissuerepair device and fixate it to such anatomical landmarks with minimalassociated tissue trauma.

SUMMARY OF THE INVENTION

According to one aspect of the present invention there is provided amethod of repairing a pelvic floor disorder comprising: (a) positioningan imaging device in or against an abdominal, rectal, perianal orvaginal cavity; and (b) advancing a surgical instrument through avaginal wall under guidance of the imaging device to thereby reach atarget tissue; and (c) using the surgical instrument to attach thetissue repair device to the target tissue.

According to further features in preferred embodiments of the inventiondescribed below, the imaging device and the surgical instrument areattached via a housing.

According to still further features in the described preferredembodiments the housing includes a guide element for guiding a path ofthe surgical instrument through a vaginal wall.

According to still further features in the described preferredembodiments the imaging device is an ultrasound transducer and the guideelement aligns the path of the surgical instrument with an imaging planeof the ultrasound transducer.

According to still further features in the described preferredembodiments the target tissue is a sacrospinous ligament.

According to still further features in the described preferredembodiments the vaginal wall is a posterior and/or lateral vaginal wall.

According to still further features in the described preferredembodiments the pelvic floor disorder is central pelvic apical prolapse.

According to still further features in the described preferredembodiments the tissue repair device is a mesh, a sling or a suture.

According to still further features in the described preferredembodiments (c) is effected via a tissue anchor attached to the tissuerepair device.

According to another aspect of the present invention there is provided asystem for repairing a pelvic floor disorder comprising a housing forinterconnecting: (a) an imaging device configured for positioning in oragainst a rectal, perianal or vaginal cavity; and (b) a surgicalinstrument for delivering a tissue repair device to a target tissuethrough a vaginal wall; wherein the housing includes a guide foraligning a path of the surgical instrument with an imaging field of theimaging device.

According to still further features in the described preferredembodiments the imaging device is an ultrasound transducer and the guideelement aligns the path of the surgical instrument with an imaging planeof the ultrasound transducer.

According to still further features in the described preferredembodiments the target tissue is a sacrospinous ligament.

According to still further features in the described preferredembodiments the vaginal wall is a posterior vaginal wall.

According to still further features in the described preferredembodiments the pelvic floor disorder is central pelvic apical prolapse.

According to still further features in the described preferredembodiments the tissue repair device is a mesh, a sling or a suture.

According to still further features in the described preferredembodiments the surgical instrument is capable of anchoring the tissuerepair device to the target tissue. According to still further featuresin the described preferred embodiments the anchoring is effected via atissue anchor forming a part of the tissue repair device.

According to still further features in the described preferredembodiments the surgical instrument is configured with a tissue piercingend.

The present invention successfully addresses the shortcomings of thepresently known configurations by providing a system that can be used toaccess pelvic floor tissues and guide a tissue repair device to ananatomical landmarks and structures through the access path.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, suitable methods andmaterials are described below. In case of conflict, the patentspecification, including definitions, will control. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings. With specific reference now tothe drawings in detail, it is stressed that the particulars shown are byway of example and for purposes of illustrative discussion of thepreferred embodiments of the present invention only, and are presentedin the cause of providing what is believed to be the most useful andreadily understood description of the principles and conceptual aspectsof the invention. In this regard, no attempt is made to show structuraldetails of the invention in more detail than is necessary for afundamental understanding of the invention, the description taken withthe drawings making apparent to those skilled in the art how the severalforms of the invention may be embodied in practice.

In the drawings:

FIGS. 1A-1E illustrate one embodiment of the present system, showing theimaging device and holder in a disassembled (FIG. 1A), and assembled(FIG. 1B) states, showing loading of the surgical instrument andattached mesh (FIGS. 1C-1D) and showing a side view of the system withthe angle between surgical instrument (A) and US holder and distance totarget (L).

FIGS. 2A-2E illustrate a pelvic floor procedure using the system ofFIGS. 1A-1D.

FIG. 3 is a prior art image of the posterior pelvic floor.

FIGS. 4A-4F are intravaginal ultrasound images of the pelvic floorshowing the SSL and IS.

FIGS. 5A-5B illustrate the anatomical landmarks identified in thecadaver study.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention is of a system and method which can be used toprovide access to anatomical landmarks as well as guide the positioningof tissue repair devices such as sutures, slings and/or meshes used torepair pelvic floor disorders.

The principles and operation of the present invention may be betterunderstood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details of construction and the arrangement of the components setforth in the following description, Example or drawings. The inventionis capable of other embodiments or of being practiced or carried out invarious ways. Also, it is to be understood that the phraseology andterminology employed herein is for the purpose of description and shouldnot be regarded as limiting.

Pelvic organ prolapse (POP), and especially apical central supportivedefect (ACSD), significantly affects the quality of life of about 20% ofthe female population. POP is typically corrected via a transabdominalor a transvaginal surgical procedure.

The transvaginal reconstruction approach is regarded as superior to thetransabdominal approach due to a shorter operative time and hospitalstay and quicker rehabilitation. However, transvaginal proceduresrequire advanced surgical skill and as such are performed by a rathersmall and highly qualified group of surgeons.

In the transvaginal procedure, a surgeon can elect to suspend thevaginal apex (VA) or the uterine cervix (UC) to thesacrospinous-ligament (SSL), sacrum, arcus tendineous fascia pelvis(ATFP) or other potentially solid supportive pelvic structures, whichare accessed via anterior or posterior vaginal wall incisions and bluntdissection of tissues.

Creating an access path to these tissues is a major challenge oftransvaginal procedures since it requires complicated navigation to thepelvic side wall (PSW), ischial spine (IS) and then to the mid SSL(MSSL) or the sacrum which carries with it a risk of damaging thebladder, rectum, blood vessels, nerves, ureters, etc.

Most POP procedure complications are attributed to the dissectionnecessary to create the tissue path to the elected tissue support site.

In order to traverse these limitations of prior art transvaginalprocedures, the present inventors have devised an approach for directlyand accurately accessing anatomical landmarks within the pelvic floorwhile minimizing tissue trauma and complications.

Thus, according to one aspect of the present invention there is provideda method of repairing a pelvic floor disorder.

As used herein, the phrase “pelvic floor disorder” refers to anydisorder of the pelvic floor that is associated with prolapse,herniation or incorrect anatomical positioning of pelvic floor tissues.

The term “repair” when used herein with reference to pelvic floordisorders refers to correction (complete or incomplete) of anatomy, via,a tissue repair device such as a suture, a mesh, a sling and/or thelike. An example of a repair procedure effected using the presentmethodology and system is described below. Centro-apical reconstructionis key to proper pelvic organ prolapse (POP) repair.

The premium supportive pelvic structure is the sacrospinous ligament(SSL), positioned at the posterior aspect of the pelvis. The SSL ishigh, thus provides a level 1 support by DeLancey. The SSL is a stableanatomical landmark and as such it is highly suitable for anchoringsupport.

The method of the present invention is effected by positioning animaging device in or against an abdominal, rectal, anal or vaginalcavity and advancing a surgical instrument through a vaginal wall underguidance of the imaging device to thereby reach a target tissue withinthe pelvic floor (e.g. SSL). Once at the target tissue, the surgicalinstrument can be used to attach a tissue repair device (e.g. mesh) tothe target tissue.

Imaging enables direct visualization of the MSSL and accurate navigationof the surgical instrument thereto providing a surgeon with transvaginalaccess to the MSSL through the lateral vaginal wall and minimizing risksassociated with posterior or anterior access (injury to the rectum orbladder).

The imaging device and surgical instrument need not be physicallyinterconnected during the procedure. However, as is further describedhereinunder, use of a housing that interconnects the imaging device andsurgical instrument and provides guides for aligning the surgicalinstrument with the imaging field of the imaging device provides severaladvantages and is presently preferred.

The imaging device can be any type of imaging device suitable for tissueimaging from within the rectal, or vaginal cavity or against theabdominal or anal cavity. Intravaginal or intra-rectal imaging deviceare preferred. Examples of suitable imaging devices include infraredimaging devices and the like. Such devices are configured so as toenable insertion into, and use within the cavity of choice.

One presently preferred imaging device is an ultrasound transducer.Ultrasound imaging from within the rectal, or vaginal cavity is wellknown in the art and commonly practiced. Gynecologists utilizetrans-vaginal ultrasound (US) for amniocentesis and ovum retrieval orfor in vitro fertilization (IVF). Urologists utilize trans-rectal US forprostate biopsies.

The surgical instrument can be any instrument capable of puncturing thevaginal wall and driving a repair device through the tissue and into thetarget site. One example of a surgical instrument includes an elongatedshaft connected at a proximal end to a working handle. The shaft lengthcan be anywhere from 3 to 15 cm with a diameter of 3-15 mm. The distalend of the shaft can be configured for tissue puncturing (beveled,double beveled or conical) and include an element (hook, harpoon, grooveetc.) for holding and delivering a repair device (suture, mesh). Thesurgical instrument can also be configured for enlarging and maintainingopen a tissue path created by the shaft. Such features of the surgicaldevice can be provided by a toroidal inflatable balloon (positionedalong the shaft length) or by outwardly expanding mechanical structures(e.g. wire meshes, struts and the like) that are capable of pushing thetissue around the shaft radially outward and holding the formed tissuechannel open to allow deployment and fixation of a repair device.

The surgical instrument can also include a sensor (at the distal tip)for identifying proximity to the tissue site of interest and an imagingmarker for identifying the tip of the shaft via the imaging device. Anexample of an echogenic marker is provided in US 20050228288.

The imaging device and surgical instrument can be used in a pelvic floorprocedure by positioning the imaging device against an abdominal or analcavity or preferably in a rectal, or vaginal cavity to provide imagingof the pelvic floor tissues of interest (target tissues as well astissue on path that are to be avoided) and using the imaging field toguide a surgical instrument through the vaginal wall (e.g. posterior)and into pelvic floor tissues.

As is mentioned hereinabove, the present method if preferably effectedan imaging device which interconnected to the surgical instrument via ahousing. Thus, according to one aspect of the present invention there isprovided system for pelvic floor repair.

The housing of the present system can interconnect any imaging device(configured for placement in any of the cavities described herein) withthe surgical instrument. The housing preferably provides a guide (track,rail, channel, groove etc.) which determines the path of insertion forthe surgical instrument through the vaginal wall and underlying tissues.Such a path is preferably aligned with the imaging field of the imagingdevice.

In configurations of the present system which include an imaging devicethat is positioned in or against cavity displaced from the vaginalcavity (e.g. anal, rectal), the housing guide is configured toaccommodate for such displacement and provide the correct path for thesurgical instrument.

One preferred configuration of the present system which is referred toherein as system 10 is illustrated in FIGS. 1A-1E. System 10 utilizes anultrasound imaging device which is configured for vaginal positioning.System 10 includes a housing 12 and an imaging device 14 (shownseparately in

FIG. 1A and assembled in FIG. 1B). Housing 12 can be fabricated from apolymer or alloy using molding or forming techniques. Since housing 12is utilized within the vaginal cavity it is fabricated from a materialthat can be sterilized and possibly re-sterilized following use(although a disposable configuration of housing 12 is preferred).

Housing 12 is typically cylindrical in shape with a length of 5-10 cmand a diameter of 1-5 cm. Housing 12 includes a lumen 16 having aproximal opening 18 through which a transducer 22 is loaded and a distalopening 20 through which an imaging head 28 of transducer 22 protrudes.Lumen 16 is configured for accommodating an imaging transducer 22 and assuch it is dimensioned for tightly fitting transducer 22. Lumen can alsoinclude elements (e.g. tabs) for releasably locking transducer 22 withinlumen. Housing 12 further includes a handle 24 to enable maneuvering ofthe transducer 18-housing 12 assembly within the vaginal cavity.

Housing 12 also includes at least one guide 26 (two shown) for guiding asurgical instrument 26 (shown in FIGS. 1C-1D). Guides 26 are configuredas open channels or slots with an internal diameter of 3-10 mm and alength of 20-150 mm. Guides 16 can be slightly angled (outward) withrespect to an imaging plane of imaging head 28. Two or more guides 26provide optional paths for a surgical instrument 30 (FIGS. 1C-1D)depending on the positioning of housing 12 and transducer 18 withrespect to the tissue.

Surgical instrument 30 includes an elongated shaft 32 which is connectedat a proximal end thereof to a handle 34. A distal end portion 36 ofshaft 32 is configured for tissue piercing and includes an element 38for holding and delivering a tissue repair device 40 to a target tissue.

As is shown in FIG. 1E, when used for delivering a suture or mesh to theSSL (described in detail below), surgical instrument 30 is angled (A)with respect to housing 12 at about 15-35 degrees. In addition, surgicalinstrument 30 is configured having a length (about 20-40 cm) forenabling delivery of the tip of surgical instrument 30 through thevaginal wall tissue and into the SSL (a distance L, about 3.5 cm) by auser holding the proximal end of surgical instrument 30.

Surgical instrument 30 is loaded through guide 26 as shown in FIGS.2C-2D and maneuvered using guide 26 to the target tissue. When utilizedwith an ultrasound transducer, the distance and angle between thelongitudinal axis of guide 26 and the imaging plane of imaging head 28is selected such that distal end portion 36 of instrument 30 advanceswithin the imaging plane. This enables a user to track distal endportion 36 of surgical instrument 30 during delivery and ascertain theposition thereof with respect to the target tissue while avoidingsurrounding tissues such as the rectum etc.

Use of a system 10 which includes an ultrasound transducer and a housingconfigured for intravaginal imaging in a pelvic floor procedure is asfollows. Housing 12 is inserted into the vaginal cavity (FIG. 2A) andimaging transducer 22 is loaded and locked within housing 12 (FIG.2B-2C).

Handle 24 of housing 12 is used to insert imaging transducer 22endovaginally in a frontal position at an angle of 40-60 degrees below“the horizon” (i.e. below the longitudinal axis of the vaginal canal)without applying pressure to the vaginal wall while imaging the rectumand levator ani muscles. Imaging transducer 22 is advanced deeper intothe vagina towards the uterine cervix or vaginal apex, it is thenrotated into a sagittal position and advanced into the direction of theischial spine. Imaging head 28 of imaging transducer 22 is used toidentify hyper-echogenic band structure corresponding to the SSL (seeFIG. 2A) or the sacro-tuberous ligament (not shown) and the length ofthe SSL is measured. Doppler US is then used to identify vascularstructures which in turn help to identify the location of the pudendalnerve. The MSSL (see FIG. 2A) is then identified and aligned with theimaging field of imaging transducer 22. Surgical instrument 30 (e.g.harpoon anchor) carrying a suture/mesh is loaded into guide 26 (FIG. 2D)and advanced through the vaginal wall at, for example, posterior or thelateral fornix (FIG. 2E) while imaging the SSL and the tip of surgicalinstrument 30 (which includes an echogenic marker). Surgical instrument30 is pushed through the MSSL to anchor a suture/mesh carried therebyinto the SSL. A suture/mesh can also be anchored to the mid-tuberosacral ligament (MTSL).

A uterine cervix connector coupled to the US transducer can be used tostandardize the procedure and in particular the insertion of thesurgical instrument through the vaginal apex. Such a connector can alsofacilitate fixation of the fibrotic ring of the uterine cervix to theMSSL-anchored repair device.

Surgical instrument 30 is then pulled out leaving a proximal end of thesuture/mesh in the vagina. The procedure is repeated on the other sideof the patient with a second suture/mesh, leaving 2 (or more—as much asthe surgeon feels needed) suture/mesh ends in the vagina.

An incision of about 1 cm can be created in the vaginal wall between the2 suture/mesh and the ends are tied or sutured to the apex of thevaginal vault or to the cervix (for uterine prolapse reconstruction).Alternatively, the uterine cervix fixation might be achieved with ananchoring device, glue or any other supportive technique.

The actual distance between imaging head 28 and the target tissue (e.g.MSSL) can be around 2 cm. As such, surgical instrument 30 loaded intoguide 26 can easily be pushed through the tissue to deliver a repairdevice (e.g. a harpoon anchor attached to suture/mesh etc.) to the MSSLunder US-Doppler imaging, thus avoiding the damage to unwantedstructures in the area (e.g. blood vessels).

System 10 of the present invention can be used with any transvaginalpelvic floor repair procedure and in any patients suffering from apelvic floor disorder which is characterized by weak soft tissues at thevaginal apex resulting in urological, gynecological, andgastroenterological anatomical changes.

The present approach can be supplemented with cervical fixation viasuture to the uterine cervix or, if the patient has undergonehysterectomy, to the vaginal apical sub-mucosal or any other vaginaltissue or to the remnants of the sacro-uterine ligaments. Such a suturecan be delivered through the vaginal mucosa or through a vaginalposterior or anterior incision. The cervical and SS or ST ligamentfixating sutures can then be attached to each other with a knot tyingdevice or a suture or clip or anchor etc.

Fixation tension can that needs to be adjusted to a tension free level,by suture tying or a ratchet mechanism (positioned at the retro-vaginalspace) can be used to adjust tension at any point desired by the surgeonfollowing the procedure.

Thus, the present invention provides a system and method which can beused to perform transvaginal pelvic floor procedures. The presentinvention is advantageous in that:

(i) it does not require posterior or anterior vaginal dissections whichcan jeopardize the rectum or bladder;

(ii) it enables direct visualization of the target tissue (e.g. MSSL)for accurate navigation of a minimally invasive surgical instrument;

(iii) US provides a clear image of the surgical instrument tip at theMSSL, since the region of convergence at the US image midline betweenthe surgical instrument tip and the MSSL is small (0.5-2.0 cm inlength);

(iv) It minimizes unwanted damage to visceral and vessel tissue duringthe procedure; and

(v) it eliminates the need for deep pelvic manual dissection andHydrodis section.

Table 1 below summarizes the advantages of the present invention overpresently used techniques.

TABLE 1 Approach Anterior or Posterior lateral vaginal wall Bluntdissection Large Minimal dissection Distance to SSL 9 cm 2.5 cmVisualization Blind Ultrasound Safety Might perforate rectum, No riskfor perforation bladder Access to SSL Long and potentially Short andSafe harmful path Bleeding Vessels and arteries Visualize with US can'tbe seen, potential Doppler to avoid for bleeding is high vessels andarteries Pudendal nerve High Very low injury risk

By minimizing bleeding and perforation risks the present invention couldbe used to bridge the gap between the advanced surgical skills requiredfor performing present POP reconstruction procedures and the averagesurgeon skills. This could render colposacropexy (CSP),colposacrospinopexy (CSSP), hysterosacropexy (HSP) andhysterosacrospinopexy (HSSP) an office procedure with minimal risk andshort recovery times.

As used herein the term “about” refers to ±10%.

Additional objects, advantages, and novel features of the presentinvention will become apparent to one ordinarily skilled in the art uponexamination of the following examples, which are not intended to belimiting. cl EXAMPLES

Reference is now made to the following examples, which together with theabove descriptions, illustrate the invention in a non limiting fashion.

Example 1 Ultrasound Imaging of the Ischial Spines and SacrospinousLigaments

The anatomy of the pelvic floor of women suffering from POP was imagedusing ultrasound in order to find out if ultrasound imaging can be usedto identify the SSL and Ischial Spine. Doppler imaging was also used toidentify blood vessels at the area of the SSL.

As is shown in FIG. 3, the SSL includes dense connective tissue andcontributes to the stability of the bony pelvis. It attaches to theischial spine laterally and lower part of the sacrum and coccyxmedially. The sacrospinous, along with the sacrotuberous ligament,divides the sciatic notches of the ischium into the lesser and greatersciatic foramen (GSF). The internal pudendal and inferior glutealvessels, sciatic nerve, and other branches of the sacral nerve plexuspass through the GSF in close proximity to the ischial spines and SSL.

On the superior or pelvic surface of the SSL lies the coccygeus muscle,which together with the levator ani muscles comprises the pelvicdiaphragm. The coccygeus muscle has the same bony attachments and runsan identical course to the SSL; thus, many refer to these structures asthe coccygeus-SSL (C-SSL) complex. The average length of the right C-SSLcomplex is 53.7 mm and that of the left C-SSL is 53.6 mm.

Methods

Two dimensional (2D) intravaginal ultrasound (US) was performed on 10female subjects diagnosed with POP using the SonoScape S8 portableUltrasound. The SSL and IS were identified in all 10 subjects.

The US transducer was inserted in the frontal position with no pressureon vaginal wall (visualizing rectum and levator ani muscles). Thetransducer was then advanced deeper into the vagina towards the uterinecervix or vaginal apex and rotated into a sagittal position while beingadvanced towards the ischial spine. Hyper echogenic bands representingthe SSL and the sacro-tuberous ligament were identified and the lengthof the SSL was measured. Vascular structures were identified usingDoppler ultrasound; the position of these vascular structures helped todetermine the location of the pudendal nerve.

Results

FIGS. 4A-4F are US images captured during the procedure. The US imageswere captured using an end-fire probe which enabled the identificationof the ischial spine and SSL, Doppler imaging enabled identification ofblood vessels.

The SSL and IS landmarks were identified in all ten subjects tested.Measurements of SSL were taken in all 10 subjects and were at theaverage described above. Vascular structures surrounding the SSL wereidentified and were used to locate the pudendal nerve running behind theSSL thus providing additional safety measures for preventing damage tothe nerve during a POP procedure. In conclusion, the present studyconclusively showed that ultrasound imaging can provide a safe‘straight-shot’ delivery path to the midpoint of the SSL.

Example 2 Cadaver Study

A cadaver study was undertaken in order to identify and measure thedistance and path between anatomical landmarks within the posteriorpelvis and the vaginal apex.

Materials and Methods

An abdominal dissection was performed on a formalin-embedded humancadaver while in a dorso-supine position. The vaginal apex wasidentified and marked and an ultrasound probe was inserted into thevaginal canal. Anatomical landmarks within the posterior pelvisincluding the MSSL, the MSTL, the ischial spine, the sacrum, the rectum,the pudendal bundle and the iliac vessel were identified and theirdistance from the apex was measured using a ruler (FIGS. 5A-5B).

Results

The results are presented in Table 2 below.

TABLE 2 Anatomical Distance from US landmark probe tip (in cm) commentsMSSL 3.5 MSTL 4.5 angled 45-60 downwards Ischial spine 4.5 Sacrum 3.5Rectum 2.5 Pudendal bundle 4.5 Iliac vessels 5.5

Conclusions

The vaginal capacity and elasticity were limited due to the fact that anon-POP formalin embedded cadaver was utilized in this study. Thus, theabove listed posterior pelvic landmarks could not be palpated uponvaginal examination thereby necessitating anatomical dissection.

The above listed anatomical structures were clearly identified followingdissection; measurements of distances between these structures and thevaginal fornix enabled identification of a safe needle path from thevaginal fornix to the MSSL or MSTL.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. All publications, patents and patentapplications mentioned in this specification are herein incorporated intheir entirety by reference into the specification, to the same extentas if each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

1-11. (canceled)
 12. A system for attaching an anchor to a ligament located outside of a tissue wall, the system comprising: a body-insertable mounting having a longitudinal axis; a working channel extending at an angle with respect to said longitudinal axis, mounted onto said body-insertable mounting; and a suture and penetrating anchor assembly which is configured to be axially displaceable along said working channel through said tissue wall and into anchoring relationship with said ligament.
 13. A system according to claim 12 and wherein said suture and penetrating anchor assembly comprises a laterally expandable anchor.
 14. A system according to claim 12 and wherein said suture and penetrating anchor assembly is configured to remain at said angle with respect to said longitudinal axis when displaced through said tissue wall into said anchoring relationship with said ligament. 